Search Results for: fda warning

40 FDA warnings to e-cig biz, but stem cell clinics allowed to keep blowing smoke

blowing-smoke-FDA-stem-cell-clinics

If the FDA can “go big” to issue 40 warning letters to the e-cig industry as it just yesterday, why has it recently only issued 1 or fewer warning letters per year to the unproven, for-profit stem cell clinic industry in the U.S., which includes hundreds of businesses blatantly operating in what seems to be a …

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FDA warning to Amniotic Therapies, LLC: impact on stem cell clinics?

Amniotic-Therapies

The FDA’s CBER branch recently issued a warning letter to Amniotic Therapies, LLC. The warning letter pertains to both AlphaGEMS-related products that are used by a number of stem cell clinics as well as problems determined at the manufacturing facility. I went to the Amniotic Therapies website, but perhaps not coincidentally it is down, which …

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3 more FDA warning letters to stem cell cosmetics makers

Resurgent-Stem-Cell-Firming-Activator

The FDA continues to be very active with warning letters against makers of stem cell cosmetics even as it has been relatively dormant on stem cell clinics. You can read past posts on the long series of warning letters to manufacturers of stem cell cosmetic cream. Three new warning letters to stem cell cream makers …

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Stem cell news bites: Mesoblast, BioTime, MS, FDA Warning, & More

Mesoblast-stock

Stem cell studies continue to make big news with a mixed bag of trends, and some good stem cell news and others not so much. Mesoblast ($MESO) had its stock suspended for quite so time recently in anticipation of a big announcement. When that news came today it was discouraging in the form of its partner …

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FDA warning to stem cell cosmetics maker raises more questions about agency itself

Ageless-Derma-Stem-Cell-and-Peptide-Anti-Wrinkle-Cream-1

The FDA has taken another action against a manufacturer of stem cell cosmetics in the form of anti-aging creams with a warning letter sent on April 20, 2016 to Crescent Health Center, Inc. The FDA noted a number of issues in the warning letter that it termed “serious violations”, but the biggest issue was that the agency …

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FDA warning points to tougher regulation of fat stem cells & clinics

FDA

Last week I blogged about how the FDA had issued a warning letter to a series of three co-owned fat stem cell clinics across the US. What does this FDA action mean on the broader stem cell clinic arena, particularly to those selling fat stem cells? The FDA is still in the process of getting public comment …

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FDA Warning Letter to Irvine Stem Cell Treatment Center Clinics Across US

Gionis-Warning-Letter

The FDA has sent a Warning Letter to the Irvine Stem Cell Treatment Center. The leader of Irvine Stem Cell Treatment Center is Dr. Thomas Gionis and the letter was addressed to him. Interestingly, this letter, dated December 30, 2015, contains redactions. At one time this clinic was part of the larger Cell Surgical Network (CSN) …

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FDA warning letter to stem cell face creams maker

Cell-Vitals

The FDA has issued a warning letter to Cell Vitals, a company that manufactures and sells stem cell face creams. Cell Vitals is apparently owned by Irene Hardy according to the letter and the business has an address in Irvine, CA. A screenshot from their website is shown below. The stem cell creams sold by Cell Vitals …

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Will stem cell clinic Celltex reinvent itself after game-changing FDA warning letter?

The FDA warning letter that Celltex received in late September (but that just went public yesterday–see my initial reaction here) is a possible game-changer for that company in my opinion. Why? The letter outlined in great detail the FDA’s concerns with how Celltex manufactures its stem cell product ranging from lack of documentation to concerns about aseptic/sterile …

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Celltex & its IRB provider both get serious FDA warning letters: Celltex response to my inquiry

Sugarland, Texas stem cell clinic, Celltex, is most well known for having done the stem cell treatment on Texas Governor Rick Perry. What’s up with Celltex this week? There has a lot of talk behind the scenes that something big has happened. Very recently Celltex put out a PR recently saying it had received a …

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